Electronic module for metered-dose inhaler, and metered-dose inhaler assembly equipped with the electronic module

Abstract

The electronic module for the metered-dose inhaler comprises a casing (10) having an external surface (17) on which a pressure detection point (16) is provided, and an electronic unit (11) and a pressure sensor (13) enclosed within the casing (10). The pressure sensor (13) is operably connected to the electronic unit (11) and the pressure detection point (16). The casing (10) comprises two hooks (19) configured to engage with the edge (9) of the housing (6) of the metered-dose inhaler (2) that houses a canister (5) containing the formulation to be dispensed. The pressure detection point (16) is located between the two hooks (19). The electronic module is mountable to the metered-dose inhaler.

Description

Technical Field

[0001] The present invention relates to an electronic module for a metered-dose inhaler (MDI) and an assembly comprising a metered-dose inhaler and an electronic module. A metered-dose inhaler is a device for dispensing a pharmaceutical formulation by inhalation. The metered-dose inhaler may be a pressurized metered-dose inhaler (pMDI). The electronic module is configured to detect inhalation by a user and other possible operating parameters of the metered-dose inhaler.

Background Art

[0002] Administration of pharmaceutical formulations by inhalation from an MDI or pMDI is generally known. MDI or pMDI inhalers with sensors and electronic devices for verifying the accuracy and regularity of drug intake by a user are also known. The inhaler may include sensors and electronic devices or may be connected to an electronic module comprising sensors and electronic devices configured to monitor correct inhalation. Drug intake can be verified by detecting inhalation by measuring the flow rate through the body of the inhaler.

[0003] The document "U.S. Patent Application Publication No. 2020 / 155773" discloses an accessory for a pMDI inhaler. The accessory comprises a fastening structure for fastening to the inhaler. The fastening structure forms a ring that slides onto the open upper end of the receiving portion of the inhaler housing. The accessory has a pressure port. When the accessory is fastened to the inhaler, the pressure port is arranged upstream of the mixing zone of the inhaler with respect to the air flow caused by inhalation by the patient through the inhaler. An electronic sensor communicates with the pressure port and senses the pressure change at the pressure port caused by the air flow.

[0004] The document "International Publication No. 2021 / 069940" discloses a bidirectional flow meter for an MDI device and an MDI device equipped with a bidirectional flow meter. The flow meter includes a collar that is attached to the inlet of the MDI device and fits around the inlet of the MDI. The flow meter has a flow path and first and second pressure tap points located in the flow path. The collar is hollow to accommodate a manometer or other component belonging to the pressure tap points. The flow path comprises a first flow path portion and a second flow path portion. The flow path portions are separated by a constriction. The first flow path portion expands away from the constriction. The second pressure tap point is located in the second flow path portion, and the first pressure tap point is located in the first flow path portion near the constriction. Measurement of the volumetric flow rates of exhalation and inhalation is performed by measuring the pressure difference before and after the constriction located in the flow path using differential pressure measurement.

[0005] U.S. Patent Application Publication No. 2017 / 290527 discloses a compliance monitoring module for a pressurized metered-dose inhaler equipped with a miniature pressure sensor. The sensor support is configured to be pneumatically coupled to the inhaler's flow path, which the user can inhale. The compliance module is clipped to the pressurized metered-dose inhaler. [Overview of the Initiative]

[0006] The applicant acknowledged that the fastening structure described in U.S. Patent Publication No. 2020 / 155773 and the collar described in International Publication No. 2021 / 069940 may affect the airflow generated by patient inhalation through the inhaler, in relation to the inhaler's operating design conditions, without additional electronic modules. In fact, both the fastening structure described in U.S. Patent Publication No. 2020 / 155773 and the collar described in International Publication No. 2021 / 069940 completely enclose the canister and the gap between the canister and the edge of the MDI, thus affecting the airflow through this gap. This may increase device resistance, reduce the airflow inhaled by the user, and hinder proper drug inhalation.

[0007] The applicant also recognized that the structure employed in International Publication No. 2021 / 069940 is very complex and could potentially hinder proper drug inhalation by the user.

[0008] The applicant further recognized that the location of the pressure ports in U.S. Patent Application Publication 2020 / 155773 requires relatively expensive, highly sensitive pressure sensors. In fact, the pressure sensors in U.S. Patent Application Publication 2020 / 155773 are located inside the accessory, spaced apart from each pressure port, and fluidly connected to the pressure ports via channels. Highly sensitive and expensive pressure sensors are required to properly detect the pressure in the pressure ports.

[0009] The objective of the present invention is to eliminate the aforementioned drawbacks of conventionally known electronic modules for metered-dose inhalers.

[0010] In particular, the object of the present invention is to provide an electronic module for a metered-dose inhaler that does not affect the overall airflow resistance of the inhaler and the effectiveness of drug inhalation when the user inhales, as much as possible.

[0011] Another objective of the present invention is to provide an electronic module for a metered-dose inhaler that ensures safe and easy attachment and removal to and from the metered-dose inhaler.

[0012] Another object of the present invention is to provide an electronic module for a metered-dose inhaler that does not require modification of a commercially available metered-dose inhaler in order to properly integrate the electronic module with the inhaler.

[0013] At least one of the above objectives is substantially achieved by the electronic module for a metered-dose inhaler and the metered-dose inhaler assembly described in the appended claims and / or one or more of the following embodiments. According to a first independent embodiment, the electronic module for a metered-dose inhaler is A casing having an external surface on which pressure detection points are provided, An electronic unit and a pressure sensor enclosed within a casing, wherein the pressure sensor is operably connected to the electronic unit and a pressure detection point, Equipped with, The casing comprises two hooks configured to engage with the edge of the housing of a metering inhaler, which contains a canister containing the dispensing formulation, or is configured to contain a canister containing The pressure detection point is located between the two hooks.

[0014] The electronic module is attached to or can be attached to the metered-dose inhaler. According to a second independent embodiment, the metered-dose inhaler assembly is A metered-dose inhaler comprising: a hollow body having a housing that contains or is configured to contain a canister containing a formulation to be dispensed; a mouthpiece that is in fluid communication with the housing; and a valve seat disposed within the hollow body between the housing and the mouthpiece and configured to contain or contain the valve dispensing nozzle of the canister; An electronic module according to the first embodiment described above or one or more of the following embodiments, It is equipped with.

[0015] The electronic module is attached to the metered-dose inhaler in a detachable manner, or is configured to be attached in a detachable manner.

[0016] The metered-dose inhaler may also be a pressurized metered-dose inhaler.

[0017] A metered-dose inhaler may include a canister containing the formulation to be dispensed.

[0018] The applicant has verified that the electronic module according to the present invention provides easy and secure coupling of the module to an inhaler, while simultaneously ensuring very little turbulence in the overall airflow through the hollow body when the user inhales the medication.

[0019] The applicant of the present application has confirmed that the electronic module according to the present invention does not require modification of commercially available inhalers on the market in order to enable connection of this module to an inhaler and correct air flow path and air flow detection by the module when connected to the inhaler.

[0020] In fact, the two hooks ensure the connection of the electronic module to the metered-dose inhaler while keeping all remaining gaps between the module and the canister free.

[0021] In addition to their hook function, the two hooks integrate the additional function of defining the flow path and transferring air at the pressure point.

[0022] In one aspect, the two hooks define a flow path therebetween, and the pressure detection point is configured to interact with the air flow across the flow path.

[0023] In one aspect, the opposing sides of the two hooks that define the flow path have a flat shape or a concave shape.

[0024] In one aspect, the two hooks define an inlet port of the flow path therebetween, and the flow path expands from the inlet port towards the free ends of the two hooks.

[0025] In one aspect, the inlet port is arranged at an outer portion of the casing. <00.valueOf(i) + 1000000;00092> In one aspect, the inlet expansion angle of the flow path at the inlet port is between 50° and 90°. the inlet expansion angle of the flow path at the inlet port is between 50° and 90°.

[0027] In one aspect, the free ends of the two hooks define an outlet opening of the flow path therebetween.

[0028] In one aspect, the pressure detection point is arranged in the middle between the inlet port and the outlet opening.

[0029] In one embodiment, the outlet divergence angle of the flow path at the outlet opening is between 0° and 20°.

[0030] In one embodiment, the average spreading angle of the flow path is between 20° and 70°.

[0031] In one embodiment, each of the two hooks has an engaging surface configured to rest on the edge of the housing.

[0032] In one embodiment, the pressure detection point is positioned between the inlet port and the plane on which the engagement surface is located.

[0033] In one embodiment, the pressure detection point is located on the central plane of the flow path.

[0034] In one embodiment, the flow path is symmetric with respect to a plane containing the respective axes of the casing. When the electronic module is mounted in a metered-dose inhaler, the flow path is symmetric with respect to a plane containing the principal axis of the housing. Alternatively, the flow path is asymmetric with respect to a plane containing the respective axes of the casing. When the electronic module is mounted in a metered-dose inhaler, the flow path is asymmetric with respect to a plane containing the principal axis of the housing.

[0035] In one embodiment, a gap for airflow is defined between the edge of the housing and the canister, surrounding the canister.

[0036] In one embodiment, two hooks that engage with the edge of the housing close only a portion of the gap.

[0037] In one embodiment, the two hooks spread around the canister at an angle between 50° and 90°, optionally at an angle of 60°. Thus, only a small portion of the gap around the canister is closed.

[0038] In one embodiment, when the electronic module is attached to the metering aspirator, the two hooks engage with the edge of the housing, and the two hooks abut against the canister, and the flow path is defined by the two hooks, the outer surface of the canister, and the outer surface of the casing on which the pressure sensing point is located.

[0039] In one embodiment, when the electronic module is attached to the metering inhaler, with two hooks engaging with the edge of the housing, the pressure sensing point is located above the edge of the housing.

[0040] In one embodiment, the flow path increases the flow velocity of the airflow above the pressure detection point, thereby increasing the pressure drop.

[0041] The applicant has verified that the electronic module according to the present invention can enhance the sensitivity of pressure detection by promoting the acceleration of the airflow at the pressure detection point. In fact, the flow path increases the pressure drop at the pressure detection point, allowing the electronic module to identify much smaller airflow rates than when the pressure sensor communicates with the airflow without a flow path.

[0042] The applicant has verified that the electronic module according to the present invention enables increased sensitivity by amplifying the pressure drop near the pressure port through the flow path of the present invention, thereby allowing the use of a relatively low-cost pressure sensor while ensuring proper airflow detection.

[0043] In one embodiment, the pressure sensor has an absolute pressure range of 0kPa to 8kPa, optionally 1kPa to 7kPa, and optionally 1kPa to 6kPa.

[0044] In one embodiment, the pressure sensor has an analog output.

[0045] In one embodiment, the pressure sensor has a sensitivity of 1 kPa / V to 3 kPa / V, and optionally 1.5 kPa / V to 2.5 kPa / V.

[0046] In one embodiment, the pressure sensor has a digital output (output in decimal counts).

[0047] In one embodiment, the pressure sensor has a sensitivity of 0.0000002 kPa / count to 0.0000006 kPa / count, and optionally 0.000000447 kPa / count.

[0048] In one embodiment, the pressure detection point is a pressure detection port that communicates with a pressure sensor and fluid.

[0049] In one embodiment, the pressure detection port is connected to the pressure sensor via a manifold, optionally an elastomer manifold.

[0050] In one embodiment, the casing has a portion complementary to a portion of the hollow body of the metered-dose inhaler; that is, the portion of the casing is molded to match a portion of the hollow body, and two hooks engage with the edge of the housing, so that when the electronic module is attached to the metered-dose inhaler, the portion of the casing abuts against the portion of the hollow body. Thus, the assembly is small and easy to handle.

[0051] In one embodiment, two hooks engage with the edge of the housing, and when the electronic module is attached to the metered-dose inhaler, the casing protrudes beyond the housing, protecting the hooks from any impact.

[0052] In one embodiment, when the electronic module is attached to the metering inhaler by engaging the two hooks with the edge of the housing, the outer surface on which the pressure sensing point is located becomes flush with the inner surface of the housing. Thus, turbulence in the airflow inside the hollow body is limited.

[0053] In one embodiment, the casing comprises projections spaced apart from two hooks, optionally elastic projections, the projections configured to clip a hollow body in a region spaced apart from the edge of the housing. The hooks and projections allow for easy engagement and disengagement.

[0054] In one embodiment, the housing extends along its respective principal axis, and the mouthpiece has its own central axis.

[0055] In one embodiment, the main axis and the central axis are inclined relative to each other such that the hollow housing is L-shaped or substantially L-shaped.

[0056] In one embodiment, the principal axis and the central axis are defined at an angle between 90° and 120°.

[0057] In one embodiment, when the electronic module is attached to the metering inhaler, the casing extends elongated along each axis, and each of these axes is parallel to the main axis of the housing.

[0058] In one embodiment, the rim is positioned at a first end of the housing, and the mouthpiece protrudes from a second end of the housing, which is positioned opposite the first end.

[0059] In one embodiment, the edge defines the opening of the housing for inserting the canister.

[0060] In one embodiment, when the canister is housed within the housing, the canister partially protrudes from the opening.

[0061] In one embodiment, the second end of the housing includes an elbow formed on the opposite side of the mouthpiece.

[0062] In one embodiment, the protruding portion of the casing is clipped onto the elbow or configured to be clipped onto the elbow.

[0063] In one embodiment, the aforementioned portion of the hollow body is the side of the hollow body opposite to the mouthpiece.

[0064] In one embodiment, the portion of the hollow body includes an elbow.

[0065] In one embodiment, the two hooks protrude from the aforementioned portion of the casing.

[0066] In one embodiment, the outer surface of the casing on which the pressure detection point is provided is bounded by the opposing sides of two hooks.

[0067] In one embodiment, the outer surface of the casing on which the pressure detection point is provided has a triangular or generally triangular contour.

[0068] In one embodiment, the outer surface of the casing on which the pressure detection point is located protrudes from a portion of the casing.

[0069] In one embodiment, the engagement surface is oriented perpendicular to the outer surface of the casing on which the pressure detection point is provided and to the portion of the casing.

[0070] In one embodiment, each of the two hooks has a projection that extends from the engagement surface and, together with the engagement surface and a portion of the casing, defines a seat for the edge of the housing.

[0071] In one embodiment, when the electronic module is attached to the metering inhaler, the inlet port is bounded by the two hooks and the outer surface of the canister, with the two hooks engaging with the edge of the housing.

[0072] In one embodiment, the inlet port opens on the outer portion of the casing, the outer portion being lateral to the outer surface of the canister and positioned alongside the outer surface of the canister.

[0073] In one embodiment, when the electronic module is attached to the metering inhaler, with two hooks engaging with the edge of the housing, the outlet opening is bounded by the two hooks and the outer surface of the canister.

[0074] In one embodiment, the electronic unit is configured to receive at least one pressure signal from a pressure sensor, examine at least one pressure signal in detail, and output a signal indicating the gas (air) flow rate, optionally indicating the gas flow rate.

[0075] In one embodiment, the electronic unit is configured to measure the flow rate of gas from at least one pressure signal.

[0076] In one embodiment, the electronic unit is configured to correlate at least one pressure signal and / or gas flow rate with correct inhalation by the user and to provide feedback to the user via at least one signaling device.

[0077] In one embodiment, the electronic module comprises one or more additional sensors operably connected to the electronic unit and configured to detect user operation and / or operation of the metered-dose inhaler and / or proper mounting of the electronic module to the metered-dose inhaler.

[0078] In one embodiment, one or more additional sensors are enclosed within the casing and / or operate on the outer surface of the casing.

[0079] In one embodiment, one or more additional sensors include an accelerometer, a proximity sensor, a motion sensor, and the like.

[0080] In one embodiment, the electronic module comprises at least one signaling device operably connected to the electronic unit and configured to alert the user of the status and / or operation of the electronic module and / or the metered-dose inhaler, for example, by providing a visual or audible signal.

[0081] In one embodiment, the electronic module comprises an electronic unit and a battery for supplying power to one or more sensors and one or more optional signaling devices.

[0082] In one embodiment, the metered-dose inhaler is operated by pressing the valve dispensing nozzle on the valve seat and pushing the canister toward the housing to deliver the formulation.

[0083] Further features and advantages will become clearer from a detailed description of preferred but non-exclusive embodiments of the electronic module for a metered-dose inhaler and the metered-dose inhaler assembly according to the present invention. [Brief explanation of the drawing]

[0084] [Figure 1A] This is a three-dimensional diagram showing a quantitative inhaler assembly comprising a quantitative inhaler and an electronic module according to the present invention. [Figure 1B] This is a three-dimensional diagram showing a quantitative inhaler assembly comprising a quantitative inhaler and an electronic module according to the present invention. [Figure 2] Figures 1A and 1B are top views of the metered-dose inhaler assembly. [Figure 3] Figures 1A, 1B, and 2 are three-dimensional diagrams of the electronic module of the metered-dose inhaler assembly. [Figure 4] This is a magnified view of Figure 3. [Figure 5] This is a front view of an enlarged portion of Figure 4. [Figure 6] Figure 5 shows the elements and the airflow through them. [Figure 7] This shows the details of the electronic module attached to the metered-dose inhaler. [Figure 8] This is a schematic diagram of the electronic module components, based on the previous figure. [Modes for carrying out the invention]

[0085] Referring to the attached drawings, Figures 1A, 1B, and 2 show a metered-dose inhaler assembly 1 according to the present invention. The metered-dose inhaler assembly 1 comprises a metered-dose inhaler 2 (MDI) and an electronic module 3. The electronic module 3 is configured to be easily attached to and removed from the metered-dose inhaler 2 without the use of tools, so that the same electronic module 3 may be coupled to another inhaler when the inhaler is worn out and needs to be replaced.

[0086] [metered dose inhaler] The metered-dose inhaler 2 may be publicly known and commercially available. The metered-dose inhaler 2 shown as an example in Figures 1A, 1B and 2 comprises a hollow body 4 or actuator and a canister 5 containing the formulation to be dispensed. The canister 5 is housed within the hollow body 4.

[0087] The hollow body 4 comprises a housing 6 that houses or is configured to house a canister 5, and a mouthpiece 7 that is in fluid communication with the housing 6. A valve seat, not shown in the accompanying drawings, is located within the hollow body 4 between the housing 6 and the mouthpiece 7. The housing 6, mouthpiece 7, and valve seat may be a single molded plastic component.

[0088] The housing 6 is a type of tubular element extending along the main axis "XX". The mouthpiece 7 is a type of tubular element extending along the central axis "YY". The main axis "XX" and the central axis "YY" are inclined relative to each other such that the hollow housing 4 is L-shaped or substantially L-shaped. In the embodiments of the attached drawings, the main axis "XX" and the central axis "YY" define an angle of approximately 100° to 110°.

[0089] The first end of the housing 6 has an opening defined by the rim 9. The second end of the housing 6 on the opposite side is connected to the mouthpiece 7, forming an elbow on the opposite side of the mouthpiece 7.

[0090] The Canister 5 may be made of aluminum or stainless steel and is equipped with a valve dispensing nozzle or a metering valve, the valve dispensing nozzle or metering valve itself being known and not shown. The formulation in the Canister contains a liquefied gas propellant (pressurized MDI) and often contains a stabilizing excipient.

[0091] As shown in Figures 1A, 1B, and 2, when the canister 5 is housed within the housing 6 of the hollow body 4, the valve dispensing nozzle of the canister 5 is positioned within the valve seat of the hollow body 4, and a portion of the canister 5 opposite the valve dispensing nozzle protrudes from the opening. A gap 8 is defined between the canister 5 and the edge 9, surrounding the canister 5.

[0092] To administer the medication, the metered-dose inhaler is activated by pushing the canister 5 toward the housing 6, that is, by pushing the portion of the canister 5 protruding from the opening 8. In this way, the valve dispensing nozzle is pressed within the valve seat, dispensing the medication. During or immediately after pressing, the user inhales through the mouthpiece 7, and the air enters the hollow body 4 through the gap 8, flows through the mouthpiece 7, where the air and medication are mixed, and then inhaled by the user through the opening of the mouthpiece 7.

[0093] [Electronic Modules] The electronic module 3 is configured to be detachably attached to the metered-dose inhaler 2, so that the same electronic module 3 may be used in a different new metered-dose inhaler after the medication in the old metered-dose inhaler has run out.

[0094] The electronic module 3 comprises a casing 10, for example, a plastic casing, which encloses the electronic unit 11 and the battery 12, and the battery 12 is, for example, a lithium battery, which is connected to the electronic unit 11 to supply power to the electronic unit 11.

[0095] Electronic module 3 is operably connected to electronic unit 11 and further comprises a sensor configured to detect, for example, user operation and / or operation of the metered-dose inhaler and / or proper mounting of electronic module 3 to metered-dose inhaler 2. The sensor may operate on the outside of casing 10 or be located inside casing 10. Electronic module 3 is operably connected to electronic unit 11 and comprises a signaling device 15, such as an LED or speaker, configured to alert the user (for example, via a visual or audible signal) about the status and / or operation of electronic module 3 and / or metered-dose inhaler 2. The electronic module 3 described herein comprises a pressure sensor 13 and an accelerometer 14. All of these electronic components are schematically shown in Figure 8 and are all enclosed and protected within casing 10.

[0096] The pressure sensor 13 is housed within the casing 10 and is in fluid communication with a pressure detection point 16, or pressure detection port, located on the outer surface 17 of the casing 10 (Figures 3, 4, 5, and 7).

[0097] For example, the hardware of the pressure sensor 13 is mounted on a printed circuit board (PCB) and connected to the pressure port via an elastomer manifold, forming a seal between the pressure sensor 13 and the casing 10. The airflow is not split between the manifold and the pressure sensor 13; only the pressure due to the airflow over the pressure port 16 is monitored during use. In fact, the air is substantially stagnant within the pressure port and the manifold.

[0098] As shown in Figure 3, the casing 10 has a portion 18 or surface that is complementary to the side of the housing 6 of the hollow body 4 of the metered-dose inhaler 2 opposite to the side from which the mouthpiece 7 protrudes. The portion 18 is concave so as to coincide with the convex, rounded side surface of the housing 6.

[0099] The casing 10 is elongated along each axis "ZZ" which is parallel to the main axis "XX" of the housing 6 when the electronic module 3 is attached to the metering inhaler 2. The first end of the casing 10 is provided with a hook assembly which protrudes from part 18 and comprises two hooks 19. The second end of the casing 10 opposite the first end along axis "ZZ" is provided with an elastic projection 20.

[0100] The outer surface 17 and pressure point 16 of the casing 10 are positioned between the two hooks 19 (Figures 3 to 7).

[0101] Referring to Figures 4 and 5, the hook assembly has an external surface 17 protruding from part 18, and two hooks 19 protruding from part 18.

[0102] Each of the two hooks 19 has a projection 21 that extends spaced apart from the portion 18 toward the second end of the casing 10. Each of the two hooks 19 has an engaging surface 22 that connects the projection 21 to the portion 18. The engaging surface 22 is oriented laterally with respect to the portion 18 and the outer surface 17 of the casing 10. The two engaging portions 22 of the hook 19 are interconnected via a further lateral surface 23 that extends between the outer surface 17 and the portion 18. The two engaging surfaces 22, together with the further lateral surface 23, form a continuous surface positioned on the plane in which it is located, which is configured to abut against the edge 9 of the housing 6 when the electronic module 3 is installed on the metering inhaler 2. Each projection 21 protrudes from its respective engaging surface 22 and, together with the engaging surface 22 and the portion 18, defines its respective seat 24 (Figure 4) for receiving and hooking the edge 9 of the housing 6.

[0103] The two hooks 19 also protrude from the outer surface 17 and define the outer surface 17. The outer surface 17 is actually bounded by the opposing sides 25 of the two hooks 19. Each of the opposing sides 25 of the two hooks 19 has a concave shape. The opposing sides 25 are closer together in the outer portion of the casing 10 located at the first end and spread out from each other as they move away from the first end (Figure 5). Thus, the outer surface 17 has an approximately triangular contour. In other embodiments, the opposing sides 25 may be flat, as shown schematically in Figure 6.

[0104] Parts of the opposing sides 25 of the two hooks 19 belonging to the projection 21 extend beyond the outer surface 17 toward the second end of the casing 10. In other words, the projection 21 extends beyond the base of the triangular outer surface 17, which coincides with the further lateral surface 23 described above (Figure 5).

[0105] The opposing sides 25 of the two hooks 19, together with the outer surface 17, define a flow path having an inlet port 26 located on the outer portion at the first end of the casing 10 (where the opposing sides 25 are closer together) and an outlet opening 27 between the free ends of the projections 21 of the two hooks 19. The flow path widens from the inlet port 26 toward the outlet opening 27.

[0106] The electronic module 3 is connected to the metered-dose inhaler 2 by hooking two hooks 19 onto the edge 9 and clipping the elastic projection 20 to the elbow of the hollow body 4. Part 18 abuts against the convex, rounded side of the housing 6.

[0107] When the electronic module 3 is coupled to the metered-dose inhaler 2, the two hooks 19 engage with the edge 9 of the housing 6, and the two hooks 19 abut against the canister 5, and the flow path is also defined by the outer surface of the canister 5. As shown in Figure 2, the inlet port 26 is bounded by the two hooks 19 and the outer surface of the canister 5. The inlet port 26 opens on the outer portion of the casing 10, which is perpendicular to the outer surface of the canister 5 and juxtaposed with the outer surface of the canister 5. Even if not shown in the drawings, when the electronic module 3 is attached to the metered-dose inhaler 2, the outlet opening 27 is also bounded by the two hooks 19 and the outer surface of the canister 5.

[0108] Figure 7 shows an electronic module 3 coupled to a metered-dose inhaler 2 that does not have a canister 5 inside. A rib 28 for holding the canister can also be seen. As shown in Figure 7, when the electronic module 3 is coupled to the metered-dose inhaler 2, the two engagement surfaces 22 and an additional lateral surface 23 abut against the edge 9 of the housing 6, the outer surface 17 is flush with the inner surface of the housing 6, and the pressure detection point 16 is located above the edge 9 of the housing 6. One of the ribs 28 may be located below the pressure detection point 16 (see also Figure 6). Furthermore, the casing 10 protrudes beyond the housing 6 and the hook 19 is protected from any impact.

[0109] As shown in Figure 2, when the electronic module 3 is attached to the metered-dose inhaler 2, the hook assembly partially surrounds the canister 5 and closes only a small portion of the gap 8. For example, the hook assembly spreads around the canister 5 at an angle Δ of approximately 60° (300° of the gap 8 is open).

[0110] In the embodiment shown in the attached figure, the inlet divergence angle α defined between the opposing sides 25 at the inlet port 26 is approximately 80°, and the outlet divergence angle β of the flow path at the outlet opening 27 is approximately 10°. The average divergence angle γ of the flow path may be, for example, approximately 30°, and the average divergence angle γ is the angle between two straight lines (a first straight line connecting one rim of the opposing sides 25 at the inlet port 26 to the rim of the same side at the outlet opening 27, and a second straight line connecting the other rim of the opposing sides 25 at the inlet port 26 to the rim of the same side at the outlet opening 27).

[0111] The flow path is symmetric with respect to the plane containing the respective axes "ZZ" of the casing 10. When the electronic module 3 is attached to the metering inhaler 2, the flow path becomes symmetric with respect to the plane containing the main axis "XX" of the housing 6.

[0112] The pressure detection point 16 is positioned on the central plane (plane of symmetry) of the flow path, midway between the inlet port 26 and the outlet opening 27, near an additional lateral surface 23, i.e., near the base of the triangular outer surface 17.

[0113] In other embodiments not shown in the attached drawings, the flow paths may be asymmetric with respect to the planes containing the respective axes "ZZ" of the casing, such that when the electronic module 3 is mounted on the metering inhaler 2, the flow paths are asymmetric with respect to the plane containing the main axis "XX" of the housing 6.

[0114] The user activates the metered inhaler 2 by pushing the canister 5 toward the housing 6, and then inhales. Air flows through the gap 8 and through the inlet port 26 toward the mouthpiece 7. The airflow entering the inlet port 26 traverses the flow path. The shape of the flow path is such that it generates a high flow velocity "V" of the airflow at the pressure detection point 16, and thus increases the pressure drop which can be easily detected by the pressure sensor 13. Figure 6 shows the higher flow velocity at a selected location (darker area) of the pressure point 16, which results in a greater pressure drop for a given inhalation flow rate.

[0115] Therefore, the pressure sensor 13 may be a low-sensitivity pressure sensor.

[0116] For example, pressure sensor 13 is an analog sensor having an analog voltage output with a pressure range of 1.03 kPa to 6.89 kPa and a sensitivity of 2.22 kPa / V. For example, pressure sensor 13 is an analog sensor having an analog voltage output with a pressure range of 0 kPa to 6 kPa and a sensitivity of 1.5 kPa / V.

[0117] The pressure sensor may also be a digital output pressure sensor having a digital output (decimal count) with a pressure range of 0kPa to 6kPa and a sensitivity of 0.000000447kPa / count. An example of a digital pressure sensor is Honeywell's MicroPressure Board Mount Pressure Sensors (MPR series).

[0118] In fact, the flow path according to the present invention maximizes the response of the pressure sensor 13 to a given flow rate through the metering inhaler 2. The pressure detection point 16 experiences a relatively large decrease with respect to a given airflow rate, and therefore the pressure drop increases, improving the performance of the pressure sensor 13.

[0119] Furthermore, the addition of this flow path does not significantly affect the airflow resistance of the metered-dose inhaler, and the resistance is equivalent to that of the metered-dose inhaler 2 without the electronic module 3 installed.

[0120] The electronic unit 11 is configured to receive a pressure signal from the pressure sensor 13, process the pressure signal, and output a signal indicating airflow or to measure the airflow rate. The electronic unit 11 is configured to correlate the pressure signal and / or airflow rate with correct inhalation by the user and provide feedback to the user via a signaling device. [Explanation of Symbols]

[0121] 1. Quantitative Inhaler Assembly 2 Metered dose inhaler 3. Electronic Modules 4 Hollow body 5 Canista 6 Housing 7 Mouthpiece 8 Gap 9. Edge 10 Casing 11 Electronic Units 12 batteries 13. Pressure Sensor 14 Accelerometer 15 Signal Devices 16 pressure detection points 17. Exterior surface 18 parts 19 Two hooks 20 Elastic protrusion 21 Protrusion 22 Engagement surface 23 Further lateral surfaces 24 Seat area 25 Opposing sides 26 Entrance Port 27 Exit opening 28 Ribs "XX" Main axis line "YY" Center axis line "ZZ" Each axis α Entrance widening angle β Exit divergence angle γ Average spread angle Δ angle

Claims

1. An electronic module for a metered-dose inhaler, wherein the electronic module is attached to or can be attached to the metered-dose inhaler, and the electronic module is A casing (10) having an external surface (17) on which a pressure detection point (16) is provided, An electronic unit (11) and a pressure sensor (13) are enclosed within the casing (10), wherein the pressure sensor (13) is operably connected to the electronic unit (11) and the pressure detection point (16), Equipped with, The casing (10) comprises two hooks (19) configured to engage with the edge (9) of the housing (6) of a metering inhaler (2) which contains a canister (5) containing a dispensing formulation, The pressure detection point (16) is positioned between the two hooks (19). An electronic module in which the two hooks (19) define a flow path between them, and the pressure detection point (16) is configured to interact with the airflow traversing the flow path.

2. The electronic module according to claim 1, wherein each of the two hooks (19) has an engaging surface (22) configured to rest on the edge (9) of the housing (6).

3. The electronic module according to claim 1 or 2, wherein the opposing sides (25) of the two hooks (19) that define the flow path have a flat or concave shape.

4. The electronic module according to claim 1, 2, or 3, wherein the two hooks (19) define an inlet port (26) of the flow path between them, and the flow path extends from the inlet port (26) toward the free ends of the two hooks (19).

5. The electronic module according to claim 4, wherein the inlet port (26) is located on the outer part of the casing (10), and the inlet divergence angle (α) of the flow path in the inlet port (26) is between 50° and 90°.

6. The electronic module according to claim 4 or 5, wherein the free ends of the two hooks (19) define an outlet opening (27) of the flow path between them, the pressure detection point (16) is positioned midway between the inlet port (26) and the outlet opening (27), and the outlet spreading angle (β) of the flow path at the outlet opening (27) is between 0° and 20°.

7. The electronic module according to any one of claims 4 to 6, wherein the average spreading angle (γ) of the flow path is between 20° and 70°.

8. The electronic module according to any one of claims 4 to 7, wherein the pressure detection point (16) is located between the inlet port (26) and the plane on which the engagement surface (22) is located.

9. The electronic module according to any one of claims 1 to 8, wherein the pressure detection point (16) is arranged on the central surface of the flow path.

10. The electronic module according to any one of claims 1 to 9, wherein the flow channels are symmetrical with respect to a plane containing each axis of the casing (10).

11. Quantitative inhaler (2), optionally a pressurized quantitative inhaler, A hollow body (4) comprising a housing (6) configured to house or house a canister (5) containing a dispensing formulation, a mouthpiece (7) in fluid communication with the housing (6), and a valve seat disposed within the hollow body (4) between the housing (6) and the mouthpiece (7) and configured to house or house a valve dispensing nozzle of the canister (5), A metered-dose inhaler (2) equipped with, An electronic module (3) according to any one of claims 1 to 10, A metered inhaler assembly comprising, A metered-dose inhaler assembly in which the electronic module (3) is attached to the metered-dose inhaler (2) in a manner that is removable, or configured to be attached in a manner that is removable.

12. A metering inhaler assembly according to claim 11, wherein a gap (8) for airflow is defined between the edge (9) of the housing (6) and the canister (5), and the two hooks (19) surrounding the canister (5) and engaged with the edge (9) of the housing (6) close only a portion of the gap (8).

13. The metered inhaler assembly according to claim 12, wherein the two hooks (19) extend around the canister (5) at an angle (Δ) that is between 50° and 90°, and optionally at 60°.

14. The electronic module according to claim 11, 12, or 13, wherein the two hooks (19) engage with the edge (9) of the housing (6), and when the electronic module (3) is attached to the metering inhaler (2), the two hooks (19) are positioned in contact with the canister (5), and the flow path is defined by the two hooks (19), the outer surface of the canister (5), and the outer surface (17) of the casing (10) on which the pressure detection point (16) is provided.

15. The electronic module according to any one of claims 11 to 14, wherein the two hooks (19) engage with the edge (9) of the housing (6) and the electronic module (3) is attached to the metering inhaler (2), and the pressure detection point (16) is above the edge (9) of the housing (6).

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